Wheeled Knee Walker for Diabetic Foot

Overseen By Audrey R Zucker-Levin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Must not be taking: Balance impairing drugs

Disqualifiers: Coronary disease, Severe conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called a wheeled knee walker to assist people with diabetic foot ulcers. The goal is to determine if this device improves healing and quality of life compared to regular care. The trial seeks individuals with a diabetic foot ulcer on one foot who can move without major discomfort. Participants should weigh less than 300 pounds and have at least one foot pulse. Those with recent heart or circulation problems, severe medical conditions, or ulcers on both legs are ineligible.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if your medications cause impaired balance or judgment, you may not be eligible to participate.

What prior data suggests that the wheeled knee walker is safe for people with diabetic foot ulcers?

Research shows that wheeled knee walkers are generally safe, but they do come with some risks. In a study of 80 patients who used these devices after foot or ankle surgery, 43% reported falling, and among those who fell, 62% sustained injuries. However, these devices make moving around much easier than using crutches or regular walkers. They reduce hand strain by 94% and make users feel 45% less tired.

While there is a risk of falling, wheeled knee walkers help take pressure off the foot, which can benefit people with diabetic foot ulcers. Although safety concerns exist, the reduced physical strain might outweigh the risks for some users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the wheeled knee walker for diabetic foot care because it offers a unique mobility solution that can potentially reduce pressure and promote healing in foot ulcers. Unlike standard care options, which typically involve offloading shoes or total contact casts, the wheeled knee walker allows patients to stay mobile without putting weight on the affected foot. This method not only enhances patient comfort and compliance but could also lead to faster recovery times and improved quality of life.

What evidence suggests that the wheeled knee walker is effective for diabetic foot ulcers?

This trial will compare a wheeled knee walker with standard care for individuals with diabetic foot ulcers. Studies have shown that a wheeled knee walker can relieve foot pressure, crucial for wound healing. Research indicates that this device is easier to use and more stable than crutches or regular walkers. Early findings suggest that it could enhance physical function and quality of life for those with foot ulcers. Although more research is needed, initial results are promising for this device as a helpful tool in managing diabetic foot conditions. ^{1 2 6 7 8}

Who Is on the Research Team?

Audrey R Zucker-Levin, PhD

Principal Investigator

University of Saskatchewan

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes and a specific type of foot ulcer (grade 1A). Participants must be under a doctor's care, weigh no more than 300lbs, be over 18 years old, mentally capable, have phone access, and at least one palpable foot pulse. Excluded are those with active infections or severe health conditions like heart failure or recent strokes.

Inclusion Criteria

currently under physician care for a DFU of one foot

willing and able to sign informed consent

weigh no more than 300lbs as this is the weight limitation of the wheeled knee walker

Exclusion Criteria

active infection

uncontrolled, severe medical conditions that place the subject at high risk for adverse events, including but not limited to severe congestive heart failure, angina pectoris, obstructive pulmonary disease

You have experienced a heart or brain-related medical event within the past six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Standardized baseline measures for each objective are performed

1 week

Treatment

Participants receive usual and customary care, with half receiving a wheeled knee walker

12 weeks

Re-evaluation at 6 and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wheeled Knee Walker

Trial Overview

The study tests if using a wheeled knee walker aids healing in diabetic foot ulcers compared to usual care. It aims to see if this device can improve wound healing and quality of life by allowing total offloading of the affected foot while being easier to use than crutches.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The Intervention Group will receive usual and customary care from their vascular specialist and they will be provided and trained to use the wheeled knee walker.

Group II: Control group Active Control 1 Intervention

The Control Group will receive usual and customary care from their vascular specialist.

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Saskatchewan Health Research Foundation

Collaborator

Trials

33

Recruited

5,100+

Published Research Related to This Trial

In a study involving 24 healthy volunteers, the wheeled knee walker was found to allow for better assisted ambulation compared to axillary crutches, as indicated by significant improvements in walking distance and self-selected walking velocity during a 6-minute walk test.

Participants reported a lower perceived exertion when using the wheeled knee walker, with 88% preferring it over crutches, suggesting it may be a more comfortable option for rehabilitation after lower extremity surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Assisted Ambulation and Perceived Exertion With the Wheeled Knee Walker and Axillary Crutches in Healthy Subjects. Kocher, BK., Chalupa, RL., Lopez, DM., et al.[2017]

The study involving 25 individuals at risk for diabetic foot ulcers found that ankle-high removable cast walkers (RCWs) combined with a contralateral limb lift improved comfort and gait, which may enhance patient adherence to offloading treatments.

While knee-high RCWs provided better offloading of the foot, they were less comfortable and resulted in slower walking speeds, suggesting that comfort is crucial for encouraging patients to consistently use offloading devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing an Offloading Device's Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to Improved Comfort and Gait. Crews, RT., Candela, J.[2019]

Patients using a front-wheeled walker after total knee replacement (TKR) surgery demonstrated faster walking velocity and longer step lengths immediately after surgery compared to those using a standard walker, indicating a potential short-term benefit in mobility.

However, by six weeks post-surgery, both walker groups showed similar improvements in walking speed and endurance, suggesting that while the wheeled walker may aid initial recovery, it does not lead to greater long-term ambulation benefits or reduced therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of assistive device prescription on gait following total knee replacement. Pasquini, SM., Peterson, ML., Rattansi, SM., et al.[2010]

Patients with diabetes-related foot ulcers showed significantly higher adherence to using knee-high removable cast walkers (RCWs) during the daytime (39.9%) compared to nighttime (20.4%), indicating a critical difference in adherence based on time of day.

Factors influencing lower adherence included being male, longer diabetes duration, and higher perceived heaviness of the RCW during the day, while nighttime adherence was affected by higher daytime activity levels and the presence of certain health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in adherence to using removable cast walker treatment during daytime and nighttime weight-bearing activities in people with diabetes-related foot ulcers. Ababneh, A., Finlayson, K., Edwards, H., et al.[2023]

Using a wheeled walker (WW) significantly slowed down older patients when passing through doors, taking an average of 12.86 seconds compared to 8.71 seconds without the walker, indicating usability challenges in tight spaces.

Most users reported difficulties with uphill (77%) and downhill (83%) walking, as well as crossing obstacles (77%), highlighting key areas for improvement in the design of intelligent WWs to enhance mobility and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problems of older persons using a wheeled walker. Lindemann, U., Schwenk, M., Klenk, J., et al.[2022]

In a study of 57 patients with diabetes-related foot ulcers, the average adherence to using knee-high removable cast walkers (RCWs) was only 33.6% of the prescribed weight-bearing activity, indicating a significant challenge in treatment compliance.

Factors associated with lower adherence included being male, having a longer duration of diabetes, not having peripheral artery disease, and perceiving the RCW as heavy, suggesting that these characteristics should be considered when prescribing offloading treatments to improve patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with adherence to using removable cast walker treatment among patients with diabetes-related foot ulcers. Ababneh, A., Finlayson, K., Edwards, H., et al.[2022]

In a study involving 11 diabetic subjects, ankle-high walkers provided similar offloading capacity for diabetic foot ulcers as knee-high walkers, suggesting they may be a more comfortable and stable option.

All walker types outperformed athletic shoes in reducing peak pressure on the foot, indicating that offloading is crucial for ulcer healing, and the lighter ankle-high walker may improve patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of strut height on offloading capacity of removable cast walkers. Crews, RT., Sayeed, F., Najafi, B.[2021]

In a study of 80 patients using wheeled knee walkers after foot or ankle surgery, 43% reported experiencing falls, with many of those individuals (62%) experiencing multiple falls, highlighting a significant safety concern.

Despite the high rate of falls, 91% of respondents expressed satisfaction with the knee walker, indicating that patients may value the mobility it provides even when safety issues arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Wheeled Knee Walker Use following Foot and Ankle Surgery or Injury. Yeoh, JC., Ruta, DJ., Murphy, GA., et al.[2022]

Participants with diabetic foot ulcers (DFUs) found the smart removable walker (smart boot) easy to use and reported a strong preference for it, especially among Hispanic or Latino users, indicating that user-friendly designs can enhance adherence to treatment.

Non-fallers expressed a greater desire to wear the smart boot longer and found it easier to manage, suggesting that addressing user experience and comfort can improve compliance with offloading devices for ulcer healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model. Finco, MG., Cay, G., Lee, M., et al.[2023]

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The Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate. The ...

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This pre-clinical study found that the WKW could be the preferred assistive device for total unilateral offloading of diabetic foot ulcers.

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The WKW significantly reduced hand loading by 94% compared to both crutches and walkers. Additionally, participants reported 45% lower exertion while using the ...

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